(13 days)
Not Found
No
The device description focuses on the material composition and physical properties of a wound dressing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a hydrogel wound dressing intended for the management of wounds, including chronic and acute wounds, providing a moist environment and serving as a barrier, which aligns with the definition of a therapeutic device.
No.
The device is a wound dressing that provides a moist environment for healing and protection, not for diagnosing conditions.
No
The device description clearly outlines a physical hydrogel wound dressing composed of various ingredients and supplied in different sizes and packaging. It is a tangible medical device, not software.
Based on the provided text, the device Radio BioAquaCare™ is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Radio BioAquaCare™'s Function: The description clearly states that Radio BioAquaCare™ is a hydrogel wound dressing intended for the management of wounds. It provides a moist environment, aids in debridement, acts as a microbial barrier, and protects the wound.
- No Testing on Samples: The device is applied directly to the wound and does not involve testing samples taken from the body.
Therefore, Radio BioAquaCare™ falls under the category of a wound dressing, which is a medical device used for topical application to wounds, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Radio BioAquaCare™ is a hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. Radio BioAquaCare™ wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light, and moderately exuding partial and full-thickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.
Under the direction of a health care professional, Radio BioAquaCare™ is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, radiation dermatitis, and (2) 2nd degree burns and donor sites.
Radio BioAquaCare™ is intended for single use only. Radio BioAquaCare™ is not intended for treatment of third degree burns.
Product codes
FRO
Device Description
Radio BioAquaCare™ is a hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. Radio BioAquaCare™ wound dressing provides an effective barner to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light, and moderately exuding partial and full-thickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.
Radio BioAquaCare™ wound dressing is composed of the following ingredients: 1) PEG.Soy protein; 2) EDTA; 3) sodium phosphate; 4) sodium chloride; 5) water; and 6) Liquid Germall Plus® as a preservative. The preservative contained in Radio BioAquaCare™ aids in providing an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. Radio BioAquaCare™ contains up to 85% water which enables the dressing to provide a moist environment even if the wound bed is dry. Radio BioAquaCare™ will not breakdown during use, so all of the Radio BioAquaCare™ components are removed from the wound when the dressings are removed. Radio BioAquaCare™ does not include any medicinal substance, animal/human tissue, or biologics. Radio BioAquaCare™ is supplied with gauze for mechanical support, and with a backing which serves to control the rate of water evaporation from the wound dressing upon application to the wounds.
Radio BioAquaCare™ is packaged in either a single use blister packages or in plastic bag. Radio BioAquaCare™ is supplied in a variety of sizes (i.e., 5 cm x 5 cm, 8 cm x 10 cm, 8 cm x 20 cm, 8 cm x 27 cm, 8 cm x 30 cm, 8 cm x 40 cm, 8 cm x 50 cm, 10 cm x 10 cm, 10 cm x 20 cm, 10 cm x 27 cm, 10 cm x 30 cm, 10 cm x 40 cm, 10 cm x 50 cm, 15 cm x 10 cm, 15 cm x 20 cm, 15 cm x 30 cm, 15 cm x 40 cm, or 15 cm x 50 cm). Radio BioAquaCare™ is manufactured under aseptic conditions in a controlled class 100 lean room environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under the direction of a health care professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Various in vitro and animal studies conducted to characterize BioAquaCare™'s biocompatibility, preservative system's effectiveness, and effectiveness in the management of different types of wounds are valid for, and directly applicable to, Radio BioAquaCare™. In all instances, Radio BioAquaCare™ functioned as intended and the performance observed was as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072068, K970693, K052643, K063517
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K080471
page 1 of 3
510(k) SUMMARY BAGTech's Radio BioAquaCare™
MAR - 5 2008
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C., 20004 (202) 637 5794 Phone: Facsimile: (202) 637 5910
Date Prepared: February 21, 2008
Name of Device and Name/Address of Sponsor
Radio BioAquaCare™ BioArtificial Gel Technologies (BAGTech), Inc. 400 de Maisonneuve West, Suite 1156 Montreal (Quebec) H3A 1L4, Canada
Common or Usual Name
Hydrogel Wound Dressing
Classification Name
Dressing, Wound, Drug
Classification
Unclassified
Product Code
FRO
Predicate Devices
BioArtificial Gel Technologies, Inc.'s BioAquaCare™ (K072068) AcryMed Inc.'s AcryDerm Gel Wound Dressing (K970693) Ceragenix Corporation's Epiceram Skin Barrier Emulsion (K052643) Healagenics, Inc.'s Healadex-P Occlusive Dressing (K063517)
1
Intended Use / Indications for Use
K080471
Page 20 of 3
Radio BioAquaCare™ is a hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. Radio BioAquaCare™ wound dressing provides an effective barner to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light, and moderately exuding partial and full-thickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.
Under the direction of a health care professional, Radio BioAquaCare™ is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, radiation dermatitis, and (2) 2nd degree burns and donor sites.
Radio BioAquaCare™ is intended for single use only. Radio BioAquaCare™ is not intended for treatment of third degree burns.
echnological Characteristics
Radio BioAquaCare™ wound dressing is composed of the following ingredients: 1) PEG.Soy protein; 2) EDTA; 3) sodium phosphate; 4) sodium chloride; 5) water; and 6) Liquid Germall Plus® as a preservative. The preservative contained in Radio BioAquaCare™ aids in providing an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. Radio BioAquaCare™ contains up to 85% water which enables the dressing to provide a moist environment even if the wound bed is dry. Radio BioAquaCare™ will not breakdown during use, so all of the Radio BioAquaCare™ components are removed from the wound when the dressings are removed. Radio BioAquaCare™ does not include any medicinal substance, animal/human tissue, or biologics. Radio BioAquaCare™ is supplied with gauze for mechanical support, and with a backing which serves to control the rate of water evaporation from the wound dressing upon application to the wounds.
Radio BioAquaCare™ is packaged in either a single use blister packages or in plastic bag. Radio BioAquaCare™ is supplied in a variety of sizes (i.e., 5 cm x 5 cm, 8 cm x 10 cm, 8 cm x 20 cm, 8 cm x 27 cm, 8 cm x 30 cm, 8 cm x 40 cm, 8 cm x 50 cm, 10 cm x 10 cm, 10 cm x 20 cm, 10 cm x 27 cm, 10 cm x 30 cm, 10 cm x 40 cm, 10 cm x 50 cm, 15 cm x 10 cm, 15 cm x 20 cm, 15 cm x 30 cm, 15 cm x 40 cm, or 15 cm x 50 cm). Radio BioAquaCare™ is manufactured under aseptic conditions in a controlled class 100 lean room environment.
erformance Data
2
K080471
Page 3 of 3
Radio BioAquaCare™ is technologically identical to BAGTech's 510(k)-cleared BioAquaCare™. Various in vitro and animal studies conducted to characterize BioAquaCare™'s biocompatibility, preservative system's effectiveness, and effectiveness in the management of different types of wounds are valid for, and directly applicable to, Radio BioAquaCare™. In all instances, Radio BioAquaCare™ functioned as intended and the performance observed was as expected.
Substantial Equivalence
Radio BioAquaCare™ is as safe and effective as the predicate devices. Radio BioAquaCare™ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. Thus, Radio BioAquaCare™ is substantially equivalent.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 2008
BioArtificial Gel Technologies (BAGTech), Inc. % Hogan and Hartson, L.L.P. Mr. Jonathan S. Kahan, Esq. 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
Re: K080471
Trade/Device Name: Radio BioAquaCare™ Regulatory Class: Unclassified Product Code: FRO Dated: February 21, 2008 Received: February 21, 2008
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. Jonathan S. Kahan, Esq.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Mullean
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known):
Device Name: Radio BioAquaCare™
Indications for Use:
Radio BioAquaCare™ is a hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. Radio BioAquaCare™ wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light, and moderately exuding partial and full-thickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce nain a
Under the direction of a health care professional, Radio BioAquaCare™ is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, radiation dermatitis, and (2) 2nd degree burns and donor sites.
Radio BioAquaCare™ is intended for single use only. Radio BioAquaCare™ is not intended for treatment of third degree burns.
Prescription Use X (Part 21 C.F.R. 801 Subpart D)
AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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